SOP on handling of alarm system of Stability Chambers

SOP on handling of alarm system of Stability Chambers

Objective:

  • To lay down a procedure for alarm system of stability chambers.

Scope:

  • This SOP is applicable to handling of alarm system of stability chambers

Responsibility:

  • Chemist or above of QC Laboratory
  • Electrician or above of Engineering department
  • Security supervisor or above

Accountability:

  • Head – Quality Control
  • Head – Engineering
  • Head – P&A department
  • Head – Quality Assurance

Procedure:

  • Control panel and local piezo sounder of alarm system of stability chambers is positioned at security room.

Stability Chambers

Control and indicators :

  • The alarm control panel uses an 80-character ( 4Lines X 20 Characters ) high viewing angle LCD display. The Display includes a long life LED backlight that remains illuminated. If AC power is lost and the system is not in alarm, the LED backlight will turn off to conserve batteries.
  • LED indicators are provided to annunciate the following conditions:

 AC Power (green)

 Alarm (red)

 Supervisory (yellow)

 Trouble (yellow)

 Alarm Silenced signals (yellow)

 Key Panel

Mounted on the main circuit board, the key panel includes a window for the  LCD  display and LED indicators as listed above. The Key panel, which is visible with the cabinet door closed, has 25 keys, including a 16 key alpha- numeric pad similar to a telephone keypad.

 Function Keys:

 Acknowledge/Step                                         Alarm Silenced

 Drill(Manual evacuate)                                   Reset (Lamp test)

 Keys labeled 1 to 9                                        Key

 # Key                                                              0 (recall) Key

 1st  Event Key                                                Clear Key

 Escape Key                                                    Mode Key

 Four Cursor Keys(Up, down, left and right)    Enter Key

Membrane / display panel

Local Piezo Sounder

  • A piezo sounder provides separate and distinct pulse rates for alarm, trouble and supervisory conditions.

Operation procedure :

  • Alarm system shall be checked at least once in a day by engineering person and record of the same shall be maintained as per Annexure No. A02 .
  • Responsible person from engineering department shall ensure that alarm system is tested correctly and maintained in line with stability chambers.
  • Any failure in temperature, humidity or power supply generate an alarm on the security  gate as well as on the stability chamber. LCD display and LED indicators becomes red.
  • Security person shall silence the alarm with the help of silence key . LCD display and LED indicators becomes yellow.
  • Security person shall read the message (reason of alarm) after pressing the Acknowledge key.
  • After this security person shall intimate to stability In-charge.
  • Stability In-charge shall rectify the problem and coordinate with security person for the reset of alarm.
  • Security person shall reset the alarm with the help of Reset Key.
  • After this security person shall ensure that there will be no message on the display and LED indicators shall be green.
  • Stability In-charge also reset the stability chamber with the help of safety controller.
  • At the off duty time and holiday security person shall intimate about alarm to engineering person and stability In-charge. Engineering person shall rectify the problem after co-ordination with stability In-charge.
  • Record of every alarm shall be maintained as per Annexure No. A01

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 List of Annexure / Formats:

S. No.Format TitleAnnexure Number
1 Log book for alarm (stability chambers)A01
2Log book for daily monitoring of

alarm system (stability chambers)

A02

References (if any).

  • Alarm system manual, Stability chamber manual.

Reason for Revision

  • Not applicable due to first version of SOP.

Abbreviation:

  • SOP     :    Standard operating procedure
  • QC       :     Quality Control
  • P&A     :     Personnel and administration
  • LCD     :     Liquid crystal display
  • LED     :     Liquid emission display
  • AC       :     Alternating current
  • 1st        :     First
Log book for alarm (stability chambers)
S.

No.

Alarm date and timeStability chamber Id. No.Type of problem/ErrorMitigationDone byChecked by
       

 

Log book for daily monitoring of alarm system (stability chambers)
S. No.DateSystem checked at (time)System

checked by

StatusRemarks
      

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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